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FDA 510(k)

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

K-Number: K180469 · 2018-11-06

ApplicantColoplast Corp.
Decision Date2018-11-06
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2018-11-06 under approval number K180469. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is a medical device that received FDA 510(k) clearance on 2018-11-06. It is manufactured by Coloplast Corp.. The 510(k) number is K180469.

When was ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent approved by the FDA?

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent received FDA 510(k) clearance on 2018-11-06, under approval number K180469.

What company makes ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is manufactured by Coloplast Corp..

What is the FDA product code for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

The FDA product code for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is FAD.

Related Clinical Trials

NCT06353594 Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI RECRUITING NCT05846893 Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease ACTIVE_NOT_RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07587099 Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I) RECRUITING NCT05731700 CVT-ISR First in Human Trial for Coronary In-Stent Restenosis COMPLETED

Related PubMed Literature

PMID: 41747807 Silicone-oil migration in prefilled syringes induces smoke-like particulates in ultra-high viscosity formulations. Journal of pharmaceutical sciences (2026)

Other Devices by Coloplast Corp.

K161672SpeediCath Flex Coude K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators K182831SabreLine and SabreGuard Laser Fibers

View all 27 devices →

Related Devices (Code: FAD)

K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation K161277ConvertX Nephroureteral Stent SystemBrightwater Medical K160891Ultrathane Endoureterotomy Stent SetCook Incorporated K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSColoplast Corp. K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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